Sinus valved glaucoma shunt

ABSTRACT

The invention relates to a device and method for treating animals, such as humans and dogs, with primary glaucoma by draining or diverting aqueous humor extraocularly comprising a shunt implant wherein the length and tubing of the shunt ensure fluid flow from the eye directly into the frontal sinus cavity via tubing. The device has crossbeam aids in anchoring the device; four slit valves to control fluid flow at required volume; and bulb that anchors in the frontal sinus cavity. The device is preferably made of medical grade radiopaque silicone rubber, and is flexible. Other improvements and a method for implanting the device are disclosed as well.

FIELD OF THE INVENTION

[0001] The present invention relates generally to the field of glaucomatreatment and glaucoma devices, in particular to a new and usefulimplantable glaucoma shunt for relieving internal pressure in ananimal's eye. More particularly, the present invention provides for adevice and method for draining or diverting aqueous humor. Even moreparticularly, the invention provides for an apparatus and method ofpreventing postoperative hypotony.

BACKGROUND OF THE INVENTION

[0002] Glaucoma is a relatively common ocular disorder in animals. Forexample, glaucoma has long been recognized as a leading cause of humanand canine blindness. The incidence of canine glaucoma, for example, is0.5%. Increased incidence however is noted in specific breeds. Despiteits importance, the long-term control of canine primary glaucoma,whether medical or surgical, continues to elude the veterinaryprofession.

[0003] The current state of the art for long term control of glaucoma inhumans and/or dogs and/or other animals (hereinafter, for convenience,sometimes collectively referred to as “animals”) includes medicalmanagement, cyclophotocoagulation and anterior chamber shunts. Forexample, anterior chamber implants are used to drain or divert fluids,such as aqueous humor. One of the disadvantages of the art is thatimplants in dogs fail to maintain normotensive intraocular pressures formore than 6 months postoperatively or do so only when combined withother forms of glaucoma therapy including medical and surgicalmanagement. Some implantable glaucoma shunts are simply cylinders thatare inserted nearly perpendicularly into the animal's eye and are heldby frictional fit by eye tissue. In other words, one of the problemswith the art is that the implantable shunts do not remain secure to thesite for the purpose of draining or diverting aqueous humorextraocularly. Furthermore, postoperative hypotony occurs when aqueoushumor production does not keep pace with outflow. Thus, it is imperativethat outflow of aqueous humor be regulated.

[0004] Other methods of draining or diverting aqueous humor in dogs havefocused on varying implants from valved to nonvalved, and alteringexplant sites from sclera, subcutaneous, or microvascular, to achieve aroute for aqueous drainage.

[0005] Studies in humans and dogs indicate that the failure of standarddrainage procedures arises mainly due to fibrosis at the site of thefiltration bleb and reduced absorptive area for aqueous humor from thescarring, or tube occlusion. Cytokines including fibroblastic growthfactor and transforming growth factors β1 and β2 have been demonstratedin the aqueous humor of dogs and humans with chronic ocular diseaseincluding primary glaucoma. These agents have marked mitogenic activityfor mesenchymal cells which are responsible for occlusion of thesefiltering sites. Blocking the effects of these fibroblast stimulatingcytokines may inhibit scarring and prevent failure of these filteringprocedures. Numerous drugs including mitomycin-C, an antineoplastic,antibiotic agent that reduces collagen production by fibroblasts, havebeen used to help prevent implant obstruction. Mitomycin-C has yieldedsome benefit in the success rates of filtration surgeries in humans,monkeys, and rabbits, and has been noted to suppress but not preventfibrosis around anterior chamber silicone implants in clinically normaldogs.

[0006] Many inflammatory diseases are associated with excessive orinappropriate cytokine activity. Cytokines activate lymphocytes andmacrophages resulting in a markedly increased production of proteolyticenzymes which rather contribute to the inflammatory process andfibrosis. Intravascular shunting of cytokine-laden aqueous humor maysuppress processes and prevent implant fibrosis. Unfortunately implantobstructions, caused by blood reflux, occurred both intraocularly and atthe intravascular implant junction. These failures in conjunction withthe inability of antineoplastics to prevent fibrosis around implants indogs attest to the need of shunting aqueous humor to an epithelium-linedsite with minimal exposure of mesenchymal tissue. The frontal sinus isan accessible epithelium-lined space and is a potential site forlong-term extraorbital diversion of aqueous humor.

[0007] Consequently, a need exists in the art for a device and a methodfor the treatment of glaucoma in animals. A need also exists in the artfor draining or diverting aqueous humor extraocularly.

[0008] In contrast to the prior art, the present invention provides fora shunt to drain or divert fluids, such as aqueous humor, extraocularly,from the anterior chamber to the frontal sinus via a valve withconsistent opening and closing pressures, and to improve frontal sinusimplantation and retention via an anchoring bulb and plug stopper.

OBJECTS OF THE INVENTION

[0009] Therefore, it is an object of the invention to provide a deviceand method for treating animals with primary glaucoma.

[0010] It is a further objective of the invention to provide a deviceand method for preventing postoperative hypotony in animals.

[0011] It is still another objective of the invention to provide adevice and method for the diverting or draining aqueous humorextraocularly, from the anterior chamber to the frontal sinus cavity inanimals.

[0012] It is still another objective of the invention to provide animplantable shunt that retains its position in the frontal sinus cavityand drains or diverts the aqueous humor extraocularly.

[0013] It is still another objective of the invention to provide animplantable shunt that controls the flow of aqueous humor flow at arequired volume.

[0014] It is still another objective of the invention to provide animplantable shunt that has a bulb wherein when the shunt is tugged backslightly during implantation, the bulb holds the device in position.

[0015] It is still another objective of the invention to provide animplantable shunt having a length and tubing to ensure fluid flow fromthe animal's eye directly into the frontal sinus cavity.

[0016] It is a specific object of the invention to provide an aqueoushumor shunt device to divert or drain aqueous humor in an animal's eyefrom the anterior chamber into the frontal sinus cavity, the shuntdevice comprising a tubing; a crossbeam affixed to the tubing; a bulbmolded to the tubing; and at least one slit valve to control fluid flowat a required volume; wherein the length and tubing of the shunt ensurefluid flow from the eye directly into the frontal sinus cavity.

[0017] Various other objects, advantages and features of the presentinvention will become readily apparent from the ensuing detaileddescription.

SUMMARY OF THE INVENTION

[0018] Accordingly, a new device for treating glaucoma is providedcomprising implanting a shunt from the anterior chamber to the frontalsinus via a hollow tube. The device is used to divert or drain aqueoushumor from the anterior chamber of an animal's eye to help decreaseintraocular pressure and thereby control glaucoma.

[0019] According to one aspect of the present invention, a shunt deviceis provided for diverting or draining fluid from an animal's eye fromthe anterior chamber into the frontal sinus cavity, the shunt devicecomprising a tubing; a crossbeam affixed to the tubing; a bulb affixedto said tubing; and at least one slit valve, wherein the tubing's lengthconducts the aqueous humor fluid flow from the anterior chamber of ananimal's eye into the frontal sinus cavity.

[0020] According to another aspect of the present invention, a methodfor treating primary glaucoma in an animal comprising implanting in ananimal's eye in need thereof an anterior chamber shunt, said shuntcomprising: a tubing; a crossbeam affixed to the tubing; a bulb; and aslit valve, wherein the tubing's length ensures aqueous humor fluid flowfrom the anterior chamber of an animal's eye directly into the frontalsinus cavity.

[0021] According to a further aspect of the present invention, a methodis provided for preventing postoperative hypotony comprising implantingin an animal's eye in need thereof a shunt, said shunt comprising atubing; a crossbeam affixed to the tubing; a bulb; and a slit valve,wherein the tubing's length allow for aqueous humor fluid flow from theanterior chamber of an animal's eye directly into the frontal sinuscavity.

[0022] The device is an implantable shunt for diverting or drainingaqueous humor from the anterior chamber of an animal's eye to thefrontal sinus via tubing, having a guide needle at one end thereof, forflushing the shunt preoperatively to ensure slit-valve function and aplug tip at an opposite end of the tubing. The guide needle is removablefrom the tubing and does not remain in the frontal sinus. Slits areformed at 90° on the tubing adjacent to the plug tip forming a conduitfor draining fluid from the anterior chamber of the eye into the frontalsinus. The slits are provided as one-way flow resisting valves in thetubing for allowing a flow of fluid to pass under resistance and in onlyone direction from the anterior chamber to the frontal sinus, wherebypressure in the anterior chamber is relieved while avoiding excessiveoutflow of aqueous humor from the anterior chamber. The shape of thedevice allows easy insertion. Crossbeam aids are affixed to the tubingfor anchoring the device to the outside (periosteum) of the frontalsinus. A bulb is molded to the tubing to anchor the shunt in the frontalsinus. When the shunt is tugged back slightly during the surgicalprocedure, the bulb holds the device in position. The length and thediameter of the tubing ensure fluid flow form the eye directly into thefrontal sinus cavity.

[0023] These and other embodiments of the invention are provided in orare obvious from the following detailed description of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The following detailed description given by way of example, butnot intended to limit the invention solely to the specific embodimentsdescribed, may best be understood in conjunction with the accompanyingdrawings in which:

[0025]FIG. 1 is a top view of the shunt of the present invention.

[0026]FIG. 2 is a side view of the present invention.

[0027]FIG. 3 is a top view of the present invention.

[0028]FIG. 4 is the perspective view of A-A on FIG. 3.

DETAILED DESCRIPTION

[0029] The present invention provides an a method for treating primaryglaucoma and an anterior chamber shunt device to drain or divert aqueoushumor in an animal's eye from the anterior chamber into the frontalsinus cavity, in which the shunt device comprises a first end, adaptedto be fitted with a guide needle, to be received within the anteriorchamber following removal of the guide needle, and a second end having acrossbeam, bulb, slits and a plug tip to be received within the frontalsinus cavity, wherein the device permits aqueous humor communicationfrom the anterior chamber to the frontal sinus cavity through the slitvalves. Fluid communication can be facilitated by intraocular pressuredirecting the aqueous humor into the slits, as described below.

[0030] The embodiments of the present invention can be used to treatanimals with primary glaucoma, particularly to drain or divert aqueoushumor extraocularly and, more particularly to prevent postoperativehypotony.

[0031] Referring now to the drawings, in which like reference numeralsare used to refer to the same or similar elements, FIG. 1 shows theglaucoma shunt device ( 10) of the invention having tubing (120), and aguide needle (130) at a first end thereof, for communicating with theanterior chamber, and a plug tip (140) at an opposite end of the tubing.Guide needle (130) is removed from tubing (120) and does not remain inthe sinus. Bulb (150) is connected to tubing (120) and anchors shunt(110) within the frontal sinus cavity. Guide needle (130) does notremain in the sinus. Slits (160) at 90° from bulb (150) to the plug tip(140) form a conduit for draining fluid from the anterior chamber of theeye. Slits (160) are provided as one-way flow resisting valves in thetubing for allowing a flow of fluid to pass under resistance and in onlyone direction to the frontal sinus, whereby pressure in the anteriorchamber is relieved while avoiding excessive outflow of fluid from theanterior chamber. Crossbeam elements (170) are affixed to tubing (120)for anchoring the device to the outside (periosteum) of the frontalsinus.

[0032] Higher pressure aqueous humor inside the animal's eye cannaturally drain through glaucoma shunt device (110) via slits (160), andtubing (120) to the frontal sinus cavity. Thus, intraocular pressure isrelieved.

[0033]FIG. 2 is a side view of the device. Guide needle (130) can be anyconventional guide needle, for example, a 20 or 22 gauge BD precisionguide needle. The guide needle is friction fitted to tubing (120) and isremovable therefrom. The overall length of tube (120) is approximately60 millimeters, with the proviso that length and tubing of the shuntensure fluid flow from the eye directly into the frontal sinus cavity.Tubing (120) has an inside diameter of approximately 0.64 millimetersand an outside diameter of approximately 1.2 millimeters. The outer andinner walls form a tubular channel to allow fluid flow from the eye intothe frontal sinus cavity. Phantom lines on FIG. 2 display the tubularchannel within the device. In all cases the length and the diameter ofthe tubing (120) must ensure fluid flow from the eye directly into thefrontal sinus cavity. Tubing (120) is made of any suitable materialknown in the art, such as, for example, medical grade radiopaquesilicone rubber, and is flexible.

[0034] At the opposite end of the device is a plug tip (140). The plugtip is made of any suitable material known in the art, such as, forexample, silicone.

[0035] Bulb (150) is approximately 3 millimeters from plug tip (140).Bulb (150) is made of any suitable material known in the art, such as,for example, clear silicone. Bulb (150) provides an anchoring aspect tothe shunt. Bulb (150) is molded onto tube (140). Bulb (150) has arounded portion (151) and an angled portion (152). Angled portion (152)forms a straight line at approximately 52° from a line perpendicular totube (120) and rounded portion (151) has a diameter of approximately 4mm. The maximum length of Bulb (150) is 4 millimeters measured throughthe tubing.

[0036] Slits (160) are formed in the tubing between the end of angledportion (152) of bulb (150) to plug tip (140). Slits (160) are at 90°degrees on the tubing and are approximately 3 millimeters in length.Slits (160) form a conduit for draining fluid from the anterior chamberof the eye into the frontal sinus cavity. Slits (160) provide one-wayflow resisting valves in the tubing for allowing a flow of fluid to passunder resistance and in only one direction to the frontal sinus, wherebypressure in the anterior chamber is relieved while avoiding excessiveoutflow of fluid from the anterior chamber. The slits (160) drain thefluid in the anterior eye at an opening pressure between 18-20 mmHg. Theslits (160) arc closed at pressures under 18 mmHg. Thus, the outflow ofaqueous humor is regulated at consistent opening and closing pressuresand the volume of aqueous humor is controlled. The slits (160) may beadjusted to be open at a different pressure.

[0037] Furthermore, the consistent opening and closing pressures preventpostoperative hypotony because the level of volume of aqueous humor isregulated. Any conventional means may be used to test and make the slits(160) in the tubing.

[0038]FIG. 3 is a top view of the device with labeled section A-A.Crossbeams (170) with crossbeam ends (181) are provided. The materialsused to make crossbeams (170) is made of any suitable material known inthe art, such as, for example fluorocarbon suture material. Thecrossbeams are glued with silicone cement to the tubing approximately 11millimeters from the plug tip (140) end of the device. However, askilled artisan would readily understand that there are other ways tosecure the crossbeams to the tubing. Crossbeams (170) form a diameter ofapproximately 11 millimeters measured through the tubing.

[0039] Crossbeams (170) help to position device (110) by providing aidsfor anchoring the device to the outside surface (periosteum) of thefrontal sinus. Crossbeams ends (181) further define adhesives to aid inthe anchoring. The materials used to make the adhesives are made of anysuitable material known in the art, such as, for example medical gradesilicone adhesive. The shape of shunt (110) allows easy insertion intothe anterior chamber and the frontal sinus cavity and when the shunt istugged back slightly during suturing the anterior chamber end, thecrossbeams (170) and bulb (150) hold device (110) in position.

[0040]FIG. 4 is the perspective view of A-A of FIG. 3. The crossbeamsfurther define left arm (182) and right arm (183). The left and rightarms may be any shape and thickness that aids in suturing the device,but preferably are 0.28 millimeters thick. The arms are affixed to thetube approximately 0.152 millimeters from the inner wall of the tubularchannel.

[0041] Although preferred embodiments of the present invention andmodifications thereof have been described in detail herein, it is to beunderstood that this invention is not limited to those preciseembodiments and modifications, and that other modifications andvariations may be affected by one skilled in the art without departingfrom the spirit and scope of the invention as defined by the appendedclaims.

What is claimed is:
 1. A shunt device for diverting or draining fluid from an animal's eye from the anterior chamber into the frontal sinus cavity, the shunt device comprising a tubing; a crossbeam affixed to the tubing; a bulb affixed to said tubing; and at least one slit valve, wherein the tubing's length conducts the aqueous humor flow from the anterior chamber of an animal's eye into the frontal sinus cavity.
 2. The shunt of claim 1, wherein the animal is a mammal.
 3. The shunt of claim 1, wherein the animal is a human.
 4. The shunt of claim 1, wherein the animal is a dog.
 5. The shunt of claim 1, wherein the shunt is adapted to be anchored to the periosteum of the frontal sinus.
 6. The shunt of claim 1, further comprising a guide needle.
 7. The shunt of claim 6, wherein the guide needle is a 20 or 22 gauge BD precision guide needle.
 8. The shunt of claim 1, wherein the bulb is molded to the tubing.
 9. The shunt of claim 1, wherein the bulb comprises an angled portion and a rounded portion.
 10. The shunt of claim 9, wherein the angle portion is 52° from a line perpendicular to the tubing.
 11. The shunt of claim 10, wherein the rounded portion has a diameter of approximately 4 mm.
 12. The shunt of claim 1, wherein the at least one slit valve has consistent opening and closing pressures.
 13. The shunt of claim 1, wherein the at least one slit valve has an opening pressure of 18-20 mmHg.
 14. The shunt of claim 1, wherein the tubing is medical grade radiopaque silicone rubber.
 15. The shunt of claim 1, wherein the tubing has an inner diameter of 0.64 millimeters and an outside diameter of 1.2 millimeters.
 16. The shunt of claim 1, wherein the bulb is clear silicone.
 17. The shunt of claim 1, wherein the crossbeams are fluorocarbon suture material.
 18. The shunt of claim 1, wherein when the shunt is tugged back slightly during implantation, the bulb holds the device in position.
 19. The shunt of claim 1, wherein the crossbeams are cemented to the tubing.
 20. The shunt of claim 1, wherein the crossbeams are approximately 11 millimeters in diameter measured through the tubing.
 21. A method for treating primary glaucoma in an animal comprising implanting in the animal's eye in need thereof an anterior chamber shunt, said shunt comprising: a tubing; a crossbeam affixed to the tubing; a bulb; and a slit valve, wherein the tubing's length ensures aqueous humor flow from the anterior chamber of an animal's eye directly into the frontal sinus cavity.
 22. The method of claim 21, wherein the shunt is anchored to the periosteum of the frontal sinus.
 23. The method of claim 21, further comprising a guide needle.
 24. The method of claim 23, wherein the guide needle is a 20 gage BD precision guide needle.
 25. The method of claim 21, wherein the bulb is molded to the tubing.
 26. The method of claim 21, wherein the bulb comprises an angled portion and a rounded portion.
 27. The method of claim 26, wherein the angle portion is 52° from a line perpendicular to the tubing.
 28. The method of claim 27, wherein the rounded portion has a diameter of approximately 4 mm.
 29. The method of claim 21, wherein the slit valves have consistent opening and closing pressures.
 30. The method of claim 21, wherein the at least one slit valve has an opening pressure of 18-20 mmHg.
 31. The method of claim 21, wherein the tubing is medical grade radiopaque silicone rubber.
 32. The method of claim 21, wherein the tubing has an inner diameter of 0.64 millimeters and an outside diameter of 1.2 millimeters.
 33. The method of claim 21, wherein the bulb is clear silicone.
 34. The method of claim 21, wherein the crossbeams are fluorocarbon suture material.
 35. The method of claim 21, wherein when the shunt is tugged back slightly during implantation, the bulb holds the device in position.
 36. The method of claim 21, wherein the crossbeams are cemented to the tubing.
 37. The method of claim 21, wherein the crossbeams are approximately 11 millimeters in diameter measured through the tubing.
 38. A method for preventing postoperative hypotony comprising implanting in an animal's eye in need thereof a shunt, said shunt comprising: a tubing; a crossbeam affixed to the tubing; a bulb; and a slit valve, wherein the tubing's length allows for aqueous humor flow from the anterior chamber of an animal's eye directly into the frontal sinus cavity.
 39. The method of claim 38, wherein the shunt is anchored to the periosteum of the frontal sinus.
 40. The method of claim 38, further comprising a guide needle.
 41. The method of claim 40, wherein the guide needle is a 20 or 22 gauge BD precision guide needle.
 42. The method of claim 38, wherein the bulb is molded to the tubing.
 43. The method of claim 38, wherein the bulb comprises an angled portion and a rounded portion.
 44. The method of claim 43, wherein the angle portion is 52° from a line perpendicular to the tubing.
 45. The method of claim 44, wherein the rounded portion has a diameter of approximately 4 mm.
 46. The method of claim 38, wherein the at least one slit valve has consistent opening and closing pressures.
 47. The method of claim 38, wherein the at least one slit valve has an opening pressure of 18-20 mmHg.
 48. The method of claim 38, wherein the tubing is medical grade radiopaque silicone rubber.
 49. The method of claim 38, wherein the tubing has an inner diameter of 0.64 millimeters and an outside diameter of 1.2 millimeters.
 50. The method of claim 38, wherein the bulb is clear silicone.
 51. The method of claim 38, wherein the crossbeams are fluorocarbon suture material.
 52. The method of claim 38, wherein when the shunt is tugged back slightly during implantation, the bulb holds the device in position.
 53. The method of claim 38, wherein the crossbeams are cemented to the tubing.
 54. The method of claim 38, wherein the crossbeams are approximately 11 millimeters in diameter measured through the tubing. 